IVC filter manufacturer C.R. Bard is facing mounting scrutiny as the medical device implant has been named in at least 27 deaths and hundreds of adverse event reports.

Consumers have questioned how the inferior vena cava filter managed to obtain FDA approval, and according to an inside source, it may have occurred through a forged signature.

Former regulatory specialist for C.R. Bard, Kay Fuller, claims she had some concerns with the IVC filter when she was hired by the manufacturer to gain FDA clearance. After early clinical testing, Fuller said that she informed Bard that until issues with the implant were fixed she wouldn’t sign the FDA application.

However, somehow Bard sent in the FDA clearance application for their Recovery IVC filter with Fuller’s signature approval. Fuller is adamant that she did not sign the application but Bard executives deny any wrongdoing on their part. 

After the FDA approved the Recovery IVC filter, Bard sold 34,000 of them. Despite a growing number of product liability lawsuits against the company, Bard has declined to recall their IVC filter but modified it and marketed it under a new name instead. 

FDA Warnings to Bard

The FDA has warned IVC filter manufacturer Bard about recent violations. The agency sent a warning letter to the company about failing to notify them about developing a IVC filter retrieval device without FDA approval.

In addition, the FDA warned Bard that its Queensbury, N.Y. facility did not have a validated cleaning process for IVC filters. Bard was also warned that executives at their Tempe, Ariz. facility violated Medical Device Reporting requirements by not informing the agency within 30 days of receiving device malfunction reports.

The U.S. Food and Drug Administration’s warning to Bard is considered serious as the agency has decided to hold-off on the marketing application of unapproved Bard devices until the company takes action to correct their concerns.

IVC Filter Complications

An inferior vena cava filter is a small, cage-like, metal trap that is placed in the main vein (vena cava) in order to trap blood clots and keep them there until the body dissolves them.

The FDA has approved use of IVC filters for the following reasons:

• Anticoagulant therapy fails to work in thromboembolic diseases
• Treating pulmonary thromboembolism when blood thinners shouldn’t be used
• Emergency treatment following massive pulmonary embolism when expected benefits of traditional therapy are reduced
• Recurring pulmonary embolism when anticoagulant use has failed

The federal agency has reported that since the release of IVC filters, manufactured by multiple companies, they have received 920 IVC filter adverse event reports. Out of those, 328 involved device migration, 146 detached device components, 70 reported IVC perforation, and 56 claimed filter fractures.

The federal agency believes that some of the events may have occurred because the IVC filters were not retrieved and left in the body for long periods of time.

IVC Filter Lawsuits

Plaintiffs filing IVC filter lawsuits claim that the implant caused life-threatening complications. In general, IVC lawsuits allege the medical device perforated the vein and traveled to nearby organs including the bowels, liver and aorta or broke into pieces which then traveled to the heart or lungs.

If you suffered from IVC filter complications, contact an attorney to find out if you have legal claim.